Percutaneous or surgical radiofrequency intravascular thrombectomy catheter system and method

ABSTRACT

The present disclosure relates to intravascular thrombectomy systems and methods for ablating a blockage and preventing the introduction of emboli into the blood stream during and after surgery performed to reduce or ablate the blockage in a blood vessel. The system includes a catheter sleeve having electrodes disposed proximate a distal end portion thereof, either at the distal end itself or axially spaced along the length of the catheter sleeve. The system further includes a capture element which is expandable to span the lumen of the vessel. The capture element is deployable downstream of the blockage. The electrodes of the catheter sleeve may be placed on one side of the blockage or on either side of the blockage.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/666,830, filed on Mar. 31, 2005, theentire content of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to intravascular thrombectomy systems andmethods and, more particularly, to intravascular systems and methodsused to ablate a blockage and to prevent the introduction of emboli intothe blood stream during and after surgery performed to reduce or ablatethe blockage in the blood vessel.

2. Background of Related Art

As is known in the industry, a thrombosis is the formation or presenceof a thrombus or blood clot inside a blood vessel or cavity of theheart. An embolus meanwhile is a thrombus or blood clot that movesthrough the bloodstream until it lodges in a narrowed vessel and blockscirculation.

The narrowing or occluding of blood vessels, such as the walls of anartery, inhibits normal blood flow. Such blockages, whether partial orfull, can have serious medical consequences depending upon theirlocation within a patient's vascular system. For example, the narrowingor blocking of the coronary vessels that supply blood to the heart maycause damage to the heart.

Various surgical procedures are currently used to remove or reduce theblockage in the blood vessels. Such procedures include balloonangioplasty, which involves inserting a balloon catheter into thenarrowed or occluded area, expanding the balloon in the narrow oroccluded area, and if necessary, placing a stent in the now expandedarea to keep it open. Another common procedure used is atherectomy wherethe lesion is cut away and removed from the vessel, or abrasivelyground, sending the small particulates downstream. Other endovascularprocedures make use of thrombectomy, drug delivery, radiation,stent-grafts, and various diagnostic devices.

On occasion, a large thrombus or a platelet-rich thrombus resistspharmacological therapy. In such instances, restoration of adequateantegrade coronary or peripheral flow necessitates application of adevice that is capable of removing the thrombus or blockage, asdescribed above. Present mechanical devices for power thrombectomyinclude ultrasound sonication, rheolytic thrombectomy, lasertransluminal extraction catheterization, aspiration catheterization, andballoon angioplasty.

Ultimately, the clinical strategy is to use any one or a combination ofprocedures disclosed above to achieve nearly complete vessel patency,improved antegrade flow, and enhanced preservation of myocardial tissue.

However, each of the above described procedures carries with it the riskthat some of the treated plaque will be disrupted, resulting in embolicparticulates released in the bloodstream. These emboli, if allowed toflow through the vascular system, may cause subsequent infarctions orischemia in the patient.

Systems have been developed to prevent the emboli from being releasedinto the bloodstream during such procedures. For example, in one system,a balloon may be used to completely occlude the artery distal (i.e.,downstream) of the area of blockage to be treated. In another system, afilter may be used to prevent emboli from being released into thebloodstream during surgical intervention.

SUMMARY

The present disclosure relates to intravascular thrombectomy systems andmethods.

According to an aspect of the present disclosure, a catheter system forablating a partial or a complete blockage of a corporal vessel isprovided. The catheter system includes a catheter sleeve having a distalend portion; a capture element disposed proximate the distal end portionof the catheter sleeve; and at least a pair of axially spaced apartelectrodes supported on the catheter sleeve at a location proximal ofthe capture element. Each electrode is connectable to a source ofelectrosurgical energy. The capture element has a first conditionwherein the capture element is retracted onto the catheter sleeve and asecond condition wherein the capture element at least substantiallyspans the entire lumen of the vessel. The catheter sleeve may beflexible and may enable pushability and trackability. The cathetersleeve may have a gauge of about 0.060 inches.

The catheter system may include a source of electrosurgical energyelectrically connectable to each electrode. The electrosurgical energysource may deliver an effective amount of energy to the electrodes toablate the blockage.

According to yet another aspect of the present disclosure, a method ofablating a blockage in a corporal vessel is provided. The methodincludes the steps of providing a catheter system configured and adaptedto ablate the blockage. The catheter system includes a catheter sleevehaving a distal end portion supporting at least a pair of electrodesthereon, and an electrosurgical energy source connectable to eachelectrode.

The method further includes the steps of introducing the catheter intothe corporal vessel, advancing the catheter sleeve through the corporalvessel to the blockage, positioning a capture element downstream of theblockage, and deploying the capture element to at least substantiallyspan the lumen of the corporal vessel. The method further includes thesteps of positioning the catheter sleeve within the corporal vessel suchthat at least one electrode is positioned in close proximity to theblockage, and activating the electrosurgical energy source to energizethe electrodes and ablate the blockage.

The method may further include the step of delivering an effectiveamount of energy for an effective amount of time to the blockage.

According to one method, the catheter assembly may include a guidewireslidably supported within a lumen of the catheter sleeve. The cathetersleeve may include a pair of electrodes operatively supported at thedistal end portion thereof. The guidewire may include a capture elementoperatively supported on a distal end portion thereof. The captureelement may include a first condition wherein the capture element isretracted onto the guidewire and a second condition wherein the captureelement at least substantially spans the entire lumen of the vessel.

The method may further include the steps of extending the guidewiredistally from the catheter sleeve and through the blockage until thecapture element is disposed completely beyond the blockage; andadvancing the catheter sleeve through the corporal vessel until thedistal end portion thereof is in contact with the blockage.

According to another method, the catheter sleeve may support a captureelement proximate a distal end portion thereof. At least a pair ofaxially spaced apart electrodes is disposed on the catheter sleeve at alocation proximal of the capture element.

The method may further include the step of advancing the catheter sleevethrough the corporal vessel and through the blockage until the captureelement and a distal-most electrode is positioned distal of theblockage.

Each electrode of the catheter system may be electrically independentfrom one another.

Additional objects and advantages of the disclosure will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

Both the foregoing general description and the following detaileddescription are exemplary and exploratory only and are not restrictiveof the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention. In the drawings:

FIG. 1 is schematic illustration of a thrombectomy catheter systemaccording to an embodiment of the present disclosure;

FIG. 2 is an enlarged view of the indicated area of detail of FIG. 1,illustrating the thrombectomy catheter system in a first condition;

FIG. 3 is an enlarged view of the indicated area of detail of FIG. 1,illustrating the thrombectomy catheter system in a second condition;

FIGS. 4A-4D illustrate a generalized sequence of steps for use of thethrombectomy catheter system of FIGS. 1-3 for restoration of flow pastthe occluded site;

FIG. 5 is an enlarged schematic illustration of the thrombectomycatheter system of FIG. 4D, shown in a deployed condition within a bloodvessel; and

FIG. 6 is an enlarged schematic illustration of a thrombectomy cathetersystem, in accordance with another embodiment of the present disclosure,shown in a deployed condition within a blood vessel.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference will now be made in detail to the present embodiments of thedisclosure, examples of which are illustrated in the accompanyingdrawings. Wherever possible, identical or similar reference numeralswill be used throughout the drawings to refer to similar or likeelements.

The present disclosure provides for devices and methods for ablating ablockage and for preventing the introduction of emboli into the bloodstream during and after surgery performed to reduce or ablate theblockage in the blood vessel. As used herein, and “occlusion,”“blockage,” or “stenosis” refers to both complete and partial blockagesof the vessel.

Additionally, as used herein, “proximal” refers to that portion of thedevice or apparatus located closest to the user, and “distal” refers tothat portion of the device or apparatus located furthest from the user.

Referring initially to FIGS. 1-3, a thrombectomy catheter system, inaccordance with an embodiment of the present disclosure, is generallydesignated 100. Thrombectomy catheter system 100 includes an elongatecatheter sleeve 102 having a substantially tubular configuration.Catheter sleeve 102 defines a lumen 103 (see FIG. 2) extending at leastsubstantially entirely therethrough. Catheter sleeve 102 includes aproximal end portion 106 connected to and/or supporting a handle, hub ormanifold 104, and a distal end portion 108 configured for passage of anelongated shaft 120 therethrough. Catheter sleeve 102 is fabricatedutilizing suitable technology to provide catheter sleeve walls havingpredetermined flexibility characteristics that can allow preciseintravascular navigation, pushability and trackability.

Thrombectomy catheter system 100 includes at least one electrode 110disposed at and/or supported at distal end portion 108 of cathetersleeve 102. Desirably, a pair of electrodes 110 a, 110 b is provided atdistal end portion 108 of catheter sleeve 102. Each electrode 110 a, 110b is electrically connectable to a source of electrosurgical energy,such as, for example, an electrosurgical generator “G”, via electricalconduits or wires 112 extending through lumen 103 of catheter sleeve 102and through hub 104. Each electrode 110 may be electrically isolatedand/or independent from one another.

As is described in greater detail below, electrodes 110 a, 110 b arepreferably used to emulsify emboli or thrombi entrained in fluid flows(i.e., vessels) to prevent clogging of the channel or to ablate theembolus or thrombus to unclog the channel.

As seen in FIGS. 1-3, thrombectomy catheter system 100 further includesa shaft or guidewire 120 extendable through lumen 103 of catheter sleeve102. Guidewire 120 includes a selectively deployable capture element 124disposed proximate distal end 122 thereof. In one embodiment, captureelement 124 is in the form of a filter or cage. Capture element 124includes a first condition wherein capture element 124 is collapsed orretracted onto guidewire 120, and at least a second condition whereincapture element 124 is deployed or expanded to preferably span theentire lumen of the vessel or expand into apposition with the targetedvessel. Transformation of capture element 124 may be impelled byexternal mechanical means, or by self-activating memory materialprovided within capture element 124. Such mechanical memory may beimparted to the material of capture element 124 by thermal treatment toachieve a spring temper in stainless steel, for example, or to set ashape memory in a susceptible metal alloy, such as a binarynickel-titanium (nitinol) alloy. Other suitable methods of deploying andretracting capture element 124 will be readily apparent to one havingordinary skill in the art and are incorporated into the presentdisclosure without departing from the scope and spirit of the presentdisclosure.

In one embodiment, in use, as will be described in greater detail below,guidewire 120 is inserted into the lumen of catheter sleeve 102, throughhub 104, and slidably advanced therethrough until distal end 122 ofguidewire 120 extends out through distal end portion of catheter sleeve102 and capture element 124 is positioned at or near a desired locationwithin the vessel.

In an embodiment, catheter system 100 may also be a fixed-wire system ora rapid exchange system.

Turning now to FIGS. 4A-4D and 5, an exemplary method of usingthrombectomy catheter system 100 is shown and described. FIG. 4Aschematically depicts a vessel “V” containing a blockage or clot “B”(e.g., a thrombus, embolus, etc.) completely or substantiallyrestricting blood flow therethrough. As seen in FIG. 4B, distal endportion 108 of catheter sleeve 102 is introduced into vessel “V” usingany suitable technique.

A goal of the surgical procedure is to position capture element 124 ofguidewire 120 distal of blockage “B”, and to position distal end portion108, and more particularly electrodes 110, against and/or withinblockage “B”. Accordingly, as seen in FIG. 4C, catheter sleeve 102 isadvanced through vessel “V” until electrodes 110, disposed at distal endportion 108, are in close proximity to, are in contact with, or arepositioned within, blockage “B”. With continued reference to FIG. 4C,distal end 122 of guidewire 120 is advanced through blockage “B” untilcapture element 124 is disposed distal of blockage “B”.

As seen in FIG. 4D, with capture element 124 of guidewire 120 locateddistally of blockage “B”, capture element 124 is deployed to span theentire lumen of vessel “V”. Once capture element 124 has been deployed,energy (e.g., thermal, RF, ultrasonic, electrical, plasma, etc.) isdelivered to blockage “B” via electrodes 110. An effective amount ofenergy is delivered to electrodes 110 for an effective amount of time toablate blockage “B”. During and following ablation of blockage “B”, anyparticularized thrombus and/or vapor, resulting from the ablation, iscaptured in capture element 124 of guidewire 120. In one embodiment,capture element 124 of guidewire 120 functions to trap and removeparticles and/or debris that may flow distally or downstream throughvessel “V”during the thrombectomy procedure.

As mentioned above, each electrode 110 may be electrically isolatedand/or independent from one another. Accordingly, it is envisioned andwithin the scope of the present disclosure for each electrode 110 to beindependently controlled by electrosurgical generator “G”. During theprocedure, it may be desirable to limit current flow to and betweenelectrodes 110 when a low impedance path exists between electrodes 110and a return or common electrode and/or when a high impedance pathexists between electrodes 110 and a return or common electrode.Desirably, the energy delivered to electrodes 110 is in the range fromabout 20 kHz to about 20 MHz, and in the range of from about 5 volts toabout 300 volts (RMS).

According to one embodiment and method, at least one or each electrode110 may be configured to deliver plasma or the like. The surroundingblood or other fluid media may be the medium for generating the plasma.

In an embodiment, radio-opaque markers (not explicitly shown) may beprovided along the length of catheter sleeve 102 and/or guidewire 120.In this manner, the position and location of the various elements ofthrombectomy catheter system 100 (e.g., electrodes 110, capture element124, etc.) may be monitored using conventional monitoring techniques,such as, for example, fluoroscopy and the like.

In one embodiment, thrombectomy catheter system 100 has an overall gaugethat is less than about 0.060 inches. In this manner, thrombectomycatheter system 100 may enter and pass through present embolicprotection devices that may be placed proximally of the blockage “B”during the thrombectomy procedure.

Turning now to FIG. 6, a thrombectomy catheter system, according toanother embodiment of the present disclosure, is generally shown as 200.Thrombectomy catheter system 200 includes a catheter sleeve or body 202having a distal end portion 208. Thrombectomy catheter system 200further includes at least a pair of electrodes 210 a, 210 b disposed orsupported thereon. Desirably, electrodes 210 a, 210 b are spaced anaxial distance from one another and are preferably located proximatedistal end portion 208. While only a pair of electrodes 210 a, 210 b areshown and described as being disposed on catheter sleeve 202, it iswithin the scope of the present disclosure for any suitable number ofelectrodes to be disposed along the length of catheter sleeve 202.

If more than a pair of electrodes 210 a, 210 b is provided, it may bedesirable for the electrodes to be evenly spaced from one another.Additionally, each electrode 210 a or 210 b may be electrically isolatedfrom one another. In an embodiment, radio-opaque markers 211 may beprovided along the length of catheter sleeve 202, desirably on eitherside of each electrode 210 a, 210 b. Markers 211 provide the user, underfluoroscopic visualization, with the ability to identify when at least adistal-most electrode 210 is located distally of blockage “B”. In oneembodiment, each electrode 210 a, 210 b may substantially surroundcatheter sleeve 202.

As seen in FIG. 6, thrombectomy catheter system 200 further includes acapture element 224 disposed and/or supported on distal end portion 208of catheter sleeve 202. Capture element 224 may be located distally of adistal-most electrode 210 b. Capture element 224 is substantiallysimilar to capture element 124 and will not be discussed in great detailhereinbelow.

Capture element 224 is in the form of a filter or cage. Capture element224 includes a first condition wherein capture element 224 is collapsedor retracted onto catheter sleeve 202, and at least a second conditionwherein capture element 224 is deployed or expanded to preferably spanthe entire lumen of the vessel or expands into apposition with thetargeted vessel.

With continued reference to FIG. 6, an exemplary method of usingthrombectomy catheter system 200, for performing a thrombectomyprocedure, is shown and described. Once again, thrombectomy cathetersystem 200 is introduced into vessel “V” using any suitable technique.

A goal of the surgical procedure of FIG. 6 is to position captureelement 224 through and distal of blockage “B”, and to position cathetersleeve 202 through blockage “B” such that at least one electrode, e.g.,distal-most electrode 210 b, is located distal or downstream of blockage“B” and such that at least one electrode, e.g., proximal-most electrode210 a, is located proximal of or upstream of blockage “B”. Accordingly,in use, catheter sleeve 202 is advanced through vessel “V” and throughblockage “B” until distal-most electrode 210 b is disposed distal ofblockage “B” and capture element 224 is disposed distal of blockage “B”.

As seen in FIG. 6, with capture element 224 of thrombectomy cathetersystem 200 located distally of blockage “B”, capture element 224 isdeployed to span the entire lumen of vessel “V”. Once capture element224 has been deployed, energy (e.g., thermal, RF, ultrasonic,electrical, etc.) is delivered to blockage “B” via electrodes 210 a, 210b. An effective amount of energy is delivered to and between electrodes210 a, 210 b, from electrosurgical generator “G”, for an effectiveamount of time to ablate blockage “B”. During the ablation process, theeffective amount of energy is transmitted through blockage “B” betweendistal-most electrode 210 b and proximal-most electrode 210 a.

During and following ablation of blockage “B”, any particularizedthrombus and/or vapor, resulting from the ablation, is captured incapture element 224. In one embodiment, capture element 224 functions totrap and remove particles and/or debris that may flow distally ordownstream through vessel “V” during the thrombectomy procedure.

While the devices and methods of the present disclosure have beendirected to thrombectomy procedures and the like, it is within thepresent disclosure for the devices disclosed herein to be used inconnection with other procedures equally as well, such as, for example,vascular stenosis, plaque removal, artherectomy and the like.

Various modifications may be made to the embodiments of the presentlydisclosed apparatus, devices and methods. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of embodiments. Those skilled in the art will envisionother modifications within the scope and spirit of the presentdisclosure.

1. A catheter system for ablating a partial or a complete blockage of acorporal vessel, the catheter system comprising: a catheter sleeveincluding a capture element supported thereon at a location proximal toa distal end thereof, wherein the capture element includes a firstcondition wherein the capture element is retracted onto the cathetersleeve and a second condition wherein the capture element is capable ofat least substantially spanning the entire lumen of the corporal vessel;and at least a pair of axially spaced apart electrodes supported on thecatheter sleeve at a location proximal of the capture element, whereineach of the electrodes substantially surrounds the catheter sleeve. 2.The catheter system according to claim 1, wherein each electrode isisolated from one another.
 3. The catheter system according to claim 2,wherein each electrode is electrically connectable to a source ofelectrosurgical energy.
 4. The catheter system according to claim 2,further comprising a source of electrosurgical energy electricallyconnectable to each electrode of the catheter sleeve.
 5. The cathetersystem according to claim 1, wherein the capture element forms a cagewhen in the second condition.
 6. A catheter system for ablating apartial or a complete blockage of a corporal vessel, the catheter systemcomprising: a catheter sleeve having a distal end portion; a captureelement disposed on the catheter sleeve at a location proximal to thedistal end portion of the catheter sleeve, the capture element having afirst condition wherein the capture element is retracted onto thecatheter sleeve and a second condition wherein the capture element iscapable of at least substantially spanning the entire lumen of thecorporal vessel; and at least a pair of axially spaced apart electrodessupported on the catheter sleeve at a location proximal of the captureelement, wherein each electrode is connectable to a source ofelectrosurgical energy, wherein the pair of axially spaced apartelectrodes are separated from one another by a distance such that atleast one electrode is disposed distal of the blockage and at least oneelectrode is disposed proximal of the blockage when the capture elementis in the second condition.
 7. The catheter system according to claim 6,wherein the catheter sleeve is flexible and enables pushability andtrackability.
 8. The catheter system according to claim 6, furthercomprising a source of electrosurgical energy electrically connectableto each electrode.
 9. The catheter system according to claim 8, whereinthe electrosurgical energy source delivers an effective amount of energyto the electrodes to ablate the blockage.
 10. The catheter systemaccording to claim 6, wherein the catheter sleeve has a gauge of about0.060 inches.
 11. The catheter system according to claim 6, furthercomprising at least one radio-opaque marker located in close proximityto each electrode.
 12. A method of ablating a blockage in a corporalvessel comprising the steps of: introducing a catheter sleeve into thecorporal vessel; advancing the catheter sleeve through the corporalvessel to the blockage, the catheter sleeve including a capture elementsupported thereon at a location proximal to a distal end thereof and atleast a pair of axially spaced apart electrodes supported thereon,wherein each of the electrodes substantially surrounds the cathetersleeve; positioning the capture element downstream of the blockage;deploying the capture element to at least substantially span the lumenof the corporal vessel; positioning the catheter sleeve within thecorporal vessel such that at least one electrode is positioned in closeproximity to the blockage; and activating an electrosurgical energysource to energize the electrodes and ablate the blockage.
 13. Themethod according to claim 12, further comprising the step of deliveringan effective amount of energy for an effective amount of time to theblockage.
 14. The method according to claim 12, wherein the captureelement includes a first condition wherein the capture element isretracted onto the catheter sleeve and a second condition wherein thecapture element at least substantially spans the entire lumen of thevessel.
 15. The method according to claim 12, further comprising thestep of advancing the catheter sleeve though the corporal vessel andthrough the blockage until the capture element and a distal-mostelectrode is positioned distal of the blockage.
 16. The method accordingto claim 12, wherein each electrode of the catheter sleeve iselectrically independent from one another.
 17. The method according toclaim 12, further comprising the step of positioning at least one markerproximate the electrodes to identify a location of at least oneelectrode relative to the blockage.